EP3505161A4 - Sublingual pharmaceutical composition of edaravone and (+)-2-borneol - Google Patents

Sublingual pharmaceutical composition of edaravone and (+)-2-borneol Download PDF

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Publication number
EP3505161A4
EP3505161A4 EP17845291.8A EP17845291A EP3505161A4 EP 3505161 A4 EP3505161 A4 EP 3505161A4 EP 17845291 A EP17845291 A EP 17845291A EP 3505161 A4 EP3505161 A4 EP 3505161A4
Authority
EP
European Patent Office
Prior art keywords
edaravone
borneol
pharmaceutical composition
sublingual pharmaceutical
sublingual
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP17845291.8A
Other languages
German (de)
French (fr)
Other versions
EP3505161A1 (en
EP3505161B1 (en
Inventor
Yijun Wang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Neurodawn Pharmaceutical Co Ltd
Simcere Pharmaceutical Co Ltd
Original Assignee
Yantai Yenepharma Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yantai Yenepharma Co Ltd filed Critical Yantai Yenepharma Co Ltd
Publication of EP3505161A1 publication Critical patent/EP3505161A1/en
Publication of EP3505161A4 publication Critical patent/EP3505161A4/en
Application granted granted Critical
Publication of EP3505161B1 publication Critical patent/EP3505161B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • A61K31/41521,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/45Non condensed piperidines, e.g. piperocaine having oxo groups directly attached to the heterocyclic ring, e.g. cycloheximide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP17845291.8A 2016-08-29 2017-08-23 Sublingual pharmaceutical composition of edaravone and (+)-2-borneol Active EP3505161B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610761890.7A CN107773545A (en) 2016-08-29 2016-08-29 The sublingual pharmaceutical composition of Edaravone and (+) 2 baras camphor
PCT/CN2017/098620 WO2018040989A1 (en) 2016-08-29 2017-08-23 Sublingual pharmaceutical composition of edaravone and (+)-2-borneol

Publications (3)

Publication Number Publication Date
EP3505161A1 EP3505161A1 (en) 2019-07-03
EP3505161A4 true EP3505161A4 (en) 2020-04-22
EP3505161B1 EP3505161B1 (en) 2021-05-12

Family

ID=61300111

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17845291.8A Active EP3505161B1 (en) 2016-08-29 2017-08-23 Sublingual pharmaceutical composition of edaravone and (+)-2-borneol

Country Status (10)

Country Link
US (1) US11135199B2 (en)
EP (1) EP3505161B1 (en)
JP (1) JP6751475B2 (en)
KR (1) KR102216381B1 (en)
CN (2) CN107773545A (en)
AU (1) AU2017317950B2 (en)
CA (1) CA3037089C (en)
RU (1) RU2720204C1 (en)
WO (1) WO2018040989A1 (en)
ZA (1) ZA201901866B (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109431966B (en) * 2018-04-27 2020-09-22 首都医科大学附属北京天坛医院 Edaravone pharmaceutical composition
US20220409588A1 (en) * 2019-07-18 2022-12-29 Bdr Pharmaceuticals International Private Limited Oral formulations of edaravone and method of manufacturing thereof
WO2022007831A1 (en) * 2020-07-08 2022-01-13 先声药业有限公司 Medical use of composition
US20230364059A1 (en) * 2020-08-17 2023-11-16 Simcere Pharmaceutical Co., Ltd. Stable pharmaceutical composition
CN114099500B (en) * 2020-08-26 2023-09-22 上海云晟研新生物科技有限公司 Edaravone sustained-release pharmaceutical composition, preparation method and application
CN112426433B (en) * 2020-12-23 2022-08-05 湖南中医药大学 Borneol angelica polysaccharide liposome for resisting cerebral ischemia inflammatory reaction and preparation method thereof
AU2022234307A1 (en) * 2021-03-10 2023-10-19 Giri, Rajan Shobhanath Compounds for treating conditions related to oxidative stress
CA3236969A1 (en) * 2021-11-08 2023-05-11 Zhengping Zhang Application of composition containing edaravone and dexborneol in improving or treating cognitive impairment
WO2024038471A1 (en) * 2022-08-18 2024-02-22 Bdr Pharmaceuticals International Private Limited Oral formulations of edaravone and improved method of manufacturing thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3775960D1 (en) 1986-03-10 1992-02-27 Burghart Kurt PHARMACEUTICAL PREPARATION AND METHOD FOR THE PRODUCTION THEREOF.
IE60601B1 (en) 1986-08-27 1994-07-27 Chugai Pharmaceutical Co Ltd Therapeutic agent for the treatment of disorders associated with cerebral ischemia
KR950010727B1 (en) * 1993-06-10 1995-09-22 엘지전선주식회사 Terminal for power cable
CN1263472C (en) 2002-11-29 2006-07-12 张永 Gingko drop pill for prevention and treatment of cardiovascular and cerebrovascular disease
CN1739588A (en) * 2005-09-06 2006-03-01 王衡新 Chinese medicine prepn for treating cardiac vascular diseases and its prepn
CN101524352A (en) 2008-03-04 2009-09-09 江苏先声药物研究有限公司 Composition containing 3-methyl-1-phenyl-2-pyrazoline-5-ketone
CN102485223A (en) 2010-12-01 2012-06-06 江苏先声药物研究有限公司 Pharmaceutical composition and application thereof to preparation of medicament for treating cerebrovascular disease
CN102579432B (en) * 2011-01-12 2016-05-11 江苏先声药物研究有限公司 The application of 3-methyl-1-phenyl-2-pyrazolin-5-one and 2-borneol composition
CN106794146A (en) 2014-03-04 2017-05-31 伊斯特盖特医药公司 Pharmaceutical composition for transmucosal delivering and the method for treating diabetes in the subject for needing

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
No further relevant documents disclosed *
See also references of WO2018040989A1 *

Also Published As

Publication number Publication date
EP3505161A1 (en) 2019-07-03
KR102216381B1 (en) 2021-02-18
CA3037089A1 (en) 2018-03-08
AU2017317950B2 (en) 2019-09-19
CN109906077A (en) 2019-06-18
US20200297697A1 (en) 2020-09-24
CA3037089C (en) 2021-02-16
AU2017317950A1 (en) 2019-02-21
JP6751475B2 (en) 2020-09-02
RU2720204C1 (en) 2020-04-27
ZA201901866B (en) 2020-10-28
KR20190031316A (en) 2019-03-25
CN109906077B (en) 2020-02-07
US11135199B2 (en) 2021-10-05
JP2019524893A (en) 2019-09-05
WO2018040989A1 (en) 2018-03-08
EP3505161B1 (en) 2021-05-12
CN107773545A (en) 2018-03-09

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